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RSS FeedPosted by Michael Wonder on 03 Apr 2022
Cook Medical receives FDA breakthrough device designation for Zenith Thoraco+ endovascular system
31 March 2022 - Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received breakthrough device Designation from the US FDA. ...
Posted by Michael Wonder on 24 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus vaccine candidate for the prevention of RSV in older adults
24 March 2022 - Pfizer today announced that its respiratory syncytial virus vaccine candidate, PF-06928316 or RSVpreF, received breakthrough therapy ...
Posted by Michael Wonder on 09 Mar 2022
Insightec receives FDA IDE approval and breakthrough designation for NSCLC brain mets study
9 March 2022 - Designation and approvals mark key milestones in advancing Insightec blood brain barrier clinical roadmap using acoustic ...
Posted by Michael Wonder on 07 Mar 2022
Merit Medical receives FDA breakthrough device designation for Embosphere microspheres for use in genicular artery embolisation for symptomatic knee osteoarthritis
7 March 2022 - Merit Medical Systems announced today that it has received breakthrough device designation from the U.S. FDA ...
Posted by Michael Wonder on 03 Mar 2022
AltPep receives FDA breakthrough device designation for SOBA-AD, a simple blood test for the detection of Alzheimer’s disease
1 March 2022 - AltPep Corporation today announced the U.S. FDA granted the company breakthrough device designation for its SOBA-AD diagnostic ...
Posted by Michael Wonder on 02 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women
2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough ...
Posted by Michael Wonder on 02 Mar 2022
DynamiCare Health digital therapeutic receives FDA breakthrough device designation for treatment of smoking during pregnancy
23 February 2022 - If approved, DynamiCare’s DCH-001 would become the first prescription treatment for smoking cessation demonstrated to be safe ...
Posted by Michael Wonder on 28 Feb 2022
Minimally invasive epilepsy treatment EASEE receives FDA breakthrough device designation
21 February 2022 - Precisis has received breakthrough device designation from the U.S. FDA for its EASEE brain stimulator. FDA’s ...
Posted by Michael Wonder on 25 Feb 2022
Noninvasix receives FDA breakthrough device designation for non-invasive monitoring technology for sepsis
23 February 2022 - LIVOx is first monitoring device to non-invasively monitor sepsis by detecting a key indicator of septic ...
Posted by Michael Wonder on 24 Feb 2022
FDA grants BI 1015550 breakthrough therapy designation for idiopathic pulmonary fibrosis
24 February 2022 - Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022. ...
Posted by Michael Wonder on 22 Feb 2022
NeuroSigma receives FDA breakthrough device designation for Monarch eTNS system
22 February 2022 - Monarch eTNS recognised as novel device for drug resistant epilepsy. ...
Posted by Michael Wonder on 16 Feb 2022
Bonalive Biomaterials granted FDA breakthrough device designation for a bone graft substitute that potentially protects against microbial colonisation
16 February 2022 - The Center for Devices and Radiological Health at the U.S. FDA has determined that Bonalive Orthopedics granules, ...
Posted by Michael Wonder on 16 Feb 2022
Foundation Medicine’s ctDNA monitoring assay, FoundationOne Tracker, granted breakthrough device designation by U.S. Food and Drug Administration
15 February 2022 - Foundation Medicine today announced that the U.S. FDA has granted a breakthrough device designation for its circulating ...
Posted by Michael Wonder on 16 Feb 2022
Cardiosense receives FDA breakthrough device designation for algorithm to identify patients at risk of decompensated heart failure
15 February 2022 - Cardiosense announced today that the U.S. FDA has granted the company breakthrough device status for its ...
Posted by Michael Wonder on 16 Feb 2022
Rapid Medical receives FDA breakthrough device designation for vasospasm treatment
15 February 2022 - Comaneci temporarily expands blood vessels, recognised as novel device for life-threatening disease. ...